| Primary Device ID | 00850894007636 |
| NIH Device Record Key | a2642eb4-d9e7-4be9-9244-4a385c98ac38 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Imbio RV/LV |
| Version Model Number | 2.1 |
| Company DUNS | 078397649 |
| Company Name | Imbio, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850894007636 [Primary] |
| QIH | Automated Radiological Image Processing Software |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-18 |
| Device Publish Date | 2021-08-10 |
| 00850894007605 | The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that t |
| 00850894007636 | The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that t |
| 00850894007643 | The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that t |
| 00850894007728 | The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that t |
| 00850894007766 | The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that t |